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TPLC
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Device
massager, vacuum, radio frequency induced heat
Definition
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
Product Code
PBX
Regulation Number
878.4400
Device Class
2
Premarket Reviews
Manufacturer
Decision
21 EQUIPMENT S.R.L.
SUBSTANTIALLY EQUIVALENT
1
BIOS S.R.L.
SUBSTANTIALLY EQUIVALENT
4
BTL INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
CAO GROUP, INC.
SUBSTANTIALLY EQUIVALENT
1
CAPENERGY MEDICAL S.L.
SUBSTANTIALLY EQUIVALENT
1
CAPENERGY MEDICAL SL
SUBSTANTIALLY EQUIVALENT
1
CYNOSURE LLC
SUBSTANTIALLY EQUIVALENT
1
EL..EN. ELECTROIC ENGINEERING SPA
SUBSTANTIALLY EQUIVALENT
1
EL.EN ELECTRONIC ENGINEERING SPA
SUBSTANTIALLY EQUIVALENT
1
GLOBUS SPORT AND HEALTH TECHNOLOGIES LLC
SUBSTANTIALLY EQUIVALENT
1
HEAT IN A CLICK
SUBSTANTIALLY EQUIVALENT
1
HEAT IN A CLICK LLC.
SUBSTANTIALLY EQUIVALENT
1
INMODE LTD.
SUBSTANTIALLY EQUIVALENT
1
INMODE MD LTD.
SUBSTANTIALLY EQUIVALENT
2
LUVO MEDICAL TECHNOLOGIES, INC
SUBSTANTIALLY EQUIVALENT
1
MECTRONIC MEDICALE S.R.L.
SUBSTANTIALLY EQUIVALENT
2
NEAUVIA NORTH AMERICA
SUBSTANTIALLY EQUIVALENT
1
SWIMS AMERICA CORP
SUBSTANTIALLY EQUIVALENT
3
TERMOSALUD
SUBSTANTIALLY EQUIVALENT
2
VENUS CONCEPT USA INC.
SUBSTANTIALLY EQUIVALENT
5
VIORA LTD.
SUBSTANTIALLY EQUIVALENT
3
WEERO CO.
SUBSTANTIALLY EQUIVALENT
1
WINTECARE SA
SUBSTANTIALLY EQUIVALENT
1
ZIMMER MEDIZINSYSTEME GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
4
4
2020
4
4
2021
8
8
2022
7
7
2023
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
12
12
Insufficient Information
5
5
Use of Device Problem
4
4
Improper or Incorrect Procedure or Method
3
3
Energy Output Problem
2
2
Product Quality Problem
1
1
Output Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Detachment of Device or Device Component
1
1
Electrical Shorting
1
1
Appropriate Term/Code Not Available
1
1
Patient Device Interaction Problem
1
1
Excessive Heating
1
1
Circuit Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Partial thickness (Second Degree) Burn
7
7
Full thickness (Third Degree) Burn
5
5
Burn(s)
5
5
Scar Tissue
3
3
Superficial (First Degree) Burn
3
3
Skin Infection
3
3
Swelling/ Edema
2
2
Skin Burning Sensation
2
2
Nerve Damage
2
2
Pain
2
2
Skin Discoloration
2
2
Deformity/ Disfigurement
2
2
Tissue Breakdown
1
1
Dizziness
1
1
Injury
1
1
Syncope/Fainting
1
1
Paresthesia
1
1
Unspecified Vascular Problem
1
1
Unspecified Reproductive System or Breast Problem
1
1
Scarring
1
1
Chest Pain
1
1
Erythema
1
1
Fall
1
1
Hematoma
1
1
Inflammation
1
1
Nausea
1
1
Localized Skin Lesion
1
1
Skin Disorders
1
1
Patient Problem/Medical Problem
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Subcutaneous Nodule
1
1
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